FDA.reportPublic FDA data

Barrier

Primary DI
H816DC0115S1
Brand
Barrier
Company
CERTOL INTERNATIONAL, LLC
Model
DC-0115S
Catalog number
DC-0115S-1
Device description
Disposable dental bib connnector with tape
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KLCChair, Dental, With Operative Unit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLCChair, Dental, With Operative UnitDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K922175000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K922175000HEALTHPAK CHAIR SOX BARRIERSHealthpak, Inc.1992-08-06KLC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H816DC0115S2PackageHIBCC10In Commercial Distribution
H816DC0115S1PrimaryHIBCC0
H816DC0115S0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental bibA non-sterile device intended to be worn by a patient during a dental examination or treatment procedure to function as a barrier to soiling and cross-contamination. It typically consists of a shaped piece of natural and/or synthetic material intended to be fastened around the neck and cover the front side of the upper body. This is a single-use device.

Regulatory Flags#

DUNS number
095153714
Device count
300
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H816SM43401ProChek IDSM4340SM4340-12016-09-23
H816TSI4401ProChek STSI440TSI440-12016-09-23
H816QEZ21QEZQEZ2QEZ22023-06-02
H816QEZ22QEZQEZ2QEZ22023-06-02
H816BB0312H1BarrierBB-0312HBB-0312H-12017-01-13
H816BB0528X1BARRIERBB-0528XBB-0528X-12016-09-23
H816BB2930C1BarrierBB-2930CBB-2930C-12016-09-23
H816PFL0081ShieldPFL008PFL008-12016-09-23
H816PFLEL81ShieldPFLEL8PFLEL8-12016-09-23
H816PIT1001ProChek IDPIT100PIT100-12016-09-23
H816PM24401ProView plusPM2440PM2440-12016-09-23
H816PM27901ProView plusPM2790PM2790-12016-09-23
H816PM35541ProView plusPM3554PM3554-12016-09-23
H816PM35901ProView PlusPM3590PM3590-12016-09-21
H816PM54101ProView plusPM5410PM5410-12016-09-23
H816PM75131ProView plusPM7513PM7513-12016-09-23
H816PNS1001ProTectorPNS100PNS100-12016-09-23
H816VC3380V-CideVC338VC338-12016-09-23
H816PIT1201ProChek IDPIT120PIT120-12016-09-23
H816PIT3401ProChek IDPIT340PIT340-12017-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800000996264OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.KLC2025-09-04
07899581340925Dental ChairAlliage S/A Indústrias Médico OdontológicaKLC2025-07-25
08800000995977OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.KLC2025-04-24
08800000995984OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.KLC2025-04-24
08800053083249Luvis Chair (LC700C)DENTIS CO. ,LTDKLC2024-09-19
H816MBB0312H1ProBarrierMicroCare, LLCKLC2022-10-26
H816MBB0528X1ProBarrierMicroCare, LLCKLC2022-10-26
H816MBB2930C1ProBarrierMicroCare, LLCKLC2022-10-26
H816MDC0115S1ProBarrierMicroCare, LLCKLC2022-10-26
H816MBB0312H2ProBarrierMicroCare, LLCKLC2022-10-26
H816MBB0528X2ProBarrierMicroCare, LLCKLC2022-10-26
H816MBB2930C2ProBarrierMicroCare, LLCKLC2022-10-26
H816MDC0115S2ProBarrierMicroCare, LLCKLC2022-10-26
ERICV00000110VanguardRitter Concept GmbHKLC2022-08-17
ERICVP0000110VanguardRitter Concept GmbHKLC2022-08-17
ERICVS0000110VanguardRitter Concept GmbHKLC2022-08-17
ERICVSP000110VanguardRitter Concept GmbHKLC2022-08-17
06430035420162Planmeca ChairPlanmeca OyKLC2017-05-08
H816BB0312H1BarrierCERTOL INTERNATIONAL, LLCKLC2017-01-13
H816BB0312H2BarrierCERTOL INTERNATIONAL, LLCKLC2017-01-13
H816BB0528X1BARRIERCERTOL INTERNATIONAL, LLCKLC2016-09-23
H816BB2930C1BarrierCERTOL INTERNATIONAL, LLCKLC2016-09-23
H816BB0528X2BARRIERCERTOL INTERNATIONAL, LLCKLC2016-09-23
H816BB2930C2BarrierCERTOL INTERNATIONAL, LLCKLC2016-09-23
H816DC0115S2BarrierCERTOL INTERNATIONAL, LLCKLC2016-09-23